CTSA Process Evaluation

The National Center for Research (NCRR) is seeking a professional services contract to procure a contractor to conduct a process evaluation of the Clinical and Translational Science Award (CTSA) consortium. The objective of this requirement is to provide the National Institutes of Health (NIH) with an overview of best business practices as it relates to starting a new center program. The process evaluation will also provide input into the overall outcome evaluation. The National Institutes of Health (NIH) is engaged in a series of initiatives, collectively known as the - NIH Roadmap for Medical Research(http://nihroadmap.nih.gov), that promote clinical and translational investigation and aim to improve health and prevent disease. In October 2005, the National Center for Research Resources (NCRR), on behalf of the NIH Roadmap for Medical Research, launched the Clinical and Translational Science Award (CTSA) consortium to re-engineer the clinical research enterprise. The goal of the CTSA consortium is to transform the local, regional and national environment for clinical and translational science, thereby increasing the efficiency and speed of clinical and translational research. This transformation is to be achieved by creating an academic home, which can be a Center, Department, or Institute (C/D/I), as determined by institutional circumstances that supports the discipline of clinical and translational research. The C/D/I is expected to include faculty able to conduct original research, develop graduate and postgraduate training curricula and lead programs that integrate clinical and translational science across multiple departments, schools, clinical and research institutes, and hospitals. Members of the CTSA consortium are expected to work together and adopt and disseminate best practices, policies, procedures, and other measures to advance collaborative clinical and translational research and to reduce burden on individual investigators at all academic health centers. Such collaboration will be achieved primarily through the formation of national steering committees on topics such as community engagement, informatics, communications, public-private partnerships, translational research, and others. The CTSA consortium is a trans-NIH initiative with several trans-NIH working groups that are critical to the management of the CTSA consortium. Two key working groups are the CTSA Project Team, including representatives from all 27 of the NIH ICs, and the IC Director Advisory Board for Oversight of the CTSA consortium, including a rotating Director membership of 6 IC directors. NIH awarded 12 CTSAs in FY 2006 totaling $108 million and 12 CTSAs and in FY 2007 totaling $99 million. NIH expects to increase the number of CTSA awards annually so that by 2012, 60 CTSAs will receive a total of approximately $500 million per year. For more information about the CTSA program, visit: http://www.ncrr.nih.gov/clinicaldiscipline.asp. http://www.ctsaweb.org While the CTSA consortium is designed to give institutions the flexibility to develop an appropriate academic home for clinical and translational science, all CTSA institutions are expected to contribute to the following goals of the program: - provide opportunities and resources for original research on novel methods and approaches to translational and clinical science; - provide the translational technologies and knowledge base for the spectrum of clinical and translational science, including all types and sizes of studies and specialties; - integrate translational and clinical science by fostering collaboration between departments and schools of an institution; - provide for biomedical informatics and data management; - develop partnerships with industry, foundations and community physicians; - provide research education, training and career development leading to an advanced degree (Masters or Ph.D.) for the next generation of clinical and translational researchers (including physicians, nurses, dentists, pharmacists, and other allied health professionals); - conduct self-evaluation activities and participate in a national evaluation of the CTSA program. II. Purpose of the Process Evaluation/Key Study Questions This evaluation will focus on processes associated with implementing the various aspects of the CTSA program, including the use of the CTSA Consortium to identify best practices and barriers to implementation. In order to determine if the overall CTSA program goals are being met, the process of implementing the program through the Consortium are vitally important aspects of the evaluation of the new and complex infrastructure program such as the CTSA. This study will include an initial pilot-testing of the research design including data collection procedures and instruments. Based on this pilot testing, the process evaluation design will be refined before it goes full scale. The findings from the process evaluation will be extremely useful in contextualizing both short and long term outcomes of the CTSA program on its designated goals. The CTSA program is an important program initiative within the NIH Roadmap for Medical Research. The CTSA program will complement the programs of the NIH Institutes and will work in cooperation with other NIH Roadmap activities and other relevant trans-NIH activities. The National CTSA Process Evaluation seeks to understand and track processes to implement a program as large in scope as the CTSA. The Consortium as a whole is charged with reengineering the clinical research enterprise through transforming the environment for clinical translational science at every level, from local to national, thereby increasing the efficiency and speed of clinical translational research. Without an understanding of the process of implementation, the potential impact of the program will be poorly understood. The goals of the process evaluation are the following: - Assess the mechanism of a National Consortium to create a collaborative community among the CTSA institutions that coordinates national efforts to re-engineer the biomedical research enterprise through facilitating clinical translational research and multidisciplinary research approaches. - Assess the activities that facilitate post-CTSA clinical translational research conducted by the institutions. - Assess the reduction of duplicative and/or redundant work processes associated with the conduct and management of clinical translational research projects. - Development of an approach to an integrated and comprehensive curriculum to train clinical translational scientists. - Understand the characteristics of the CTSA trainees, scholars, and mentors. - Assess strategies for re-organization within the CTSA institutions as they implement the program, especially with respect to the cooperation and collaboration among the departments, schools, and outside organizations in clinical translational research. The 6 CTSA process evaluation study questions (some of which have multiple parts) are as follows: 1. How have the CTSA institutions formed an integrated National CTSA Consortium? What has the Consortium developed as priorities and action plans? How has NIH participated in the National CTSA Consortium? 2. How do the CTSA institutions integrate clinical translational science at their institutions? How does the Consortium influence this integration? What are the models used by CTSA institutions to develop an - academic home for clinical translational research? 3. How has the CTSA program developed strategies to recruit, retain, and support the career advancement (promotion and tenure) of clinical translational science researchers? 4. What mechanisms are developed and used to increase translation of basic research into clinical studies? Involve community level clinicians into research? Improve feedback from clinical studies and community clinicians back to basic research? 5. How does the CTSA program disseminate new methods, tools, and resources into community clinical practice? 6. How does the CTSA program develop relationships with community based organizations and other outreach mechanisms? Develop strategies for increasing public knowledge of, support for, and involvement in clinical translational science? A market survey is being conducted to determine the availability and potential technical capacity of business to provide the services of this requirement. Based upon the responses to this market survey, the Government will determine if the requirement is suitable for competition on a restricted basis to small business, Veteran / Disabled Veteran entities, or on an unrestricted basis. The solicitation number for this survey is: NHLBI-RR-PB-2008-200-DE The intended procurement will be classified under North American Industry Classification System code 611710, Educational Testing, Evaluation Services, with size a standard of six million dollars. Specifically, the Contractor shall : 1. Clarify objectives, issues, and questions with the Project Officer. 2. Participate in Trans-NIH CTSA Project Team meetings, and committee meetings. 3. Develop a draft work plan for the project. 4. Develop a final work plan upon approval of Project Officer. 5. Review and revise conceptual framework if needed. 6. Prepare and present plan at during CTSA Steering Committee meeting. 7. Prepare instruments, interview guides and data extraction forms. 8. Develop Protocol for annual survey of CTSA Principal Investigators 9. Create a database 10. Conduct Pilot Test 11. Prepare OMB Generic clearance Package 12. Ensure Data Integrity 13. Data Collection on Secondary Data Sources 14. Conduct semi-structured interviews with Consortium Chairs, NIH Staff, and Representatives From Biomedical Professional Organizations. 15. Conduct Annual web-based survey with CTSA Pis 16. Conduct annual semi-structured interviews with CTSA Consortium Committees, Work Groups, and NIH Staff. 17. Survey Pis on Consortium and Wiki satisfaction. 18. Data input and cleaning 19. Schedule and Plan Case Study visits. 20. Conduct Case Study visits. 21. Data preparation and analysis 22. Analyze data for national CTSA Consortium Substudy 23. Analyze data for the CTSA Implementation Substudy. 24. Analyze data for the Scholars and Trainees Career Pathways Substudy. 25. Analyze data for Clinical and Translational Science Substudy. The Government anticipates that there will be one fixed- price contract awarded for this requirement. The proposed period of performance is October 2008 through October 2010. If your organization has the potential capacity to perform these services, please provide the following information: 1) Organization name, address, e-mail address, web site address, telephone number, type of ownership for the organization, i.e., Large Business, Small Business, Small Disadvantaged Business, 8 (a), Woman-Owned, Historically Underutilized Business Zone (HUBZone) Concern, Veteran, or Disabled Veteran; 2) Business size information which states, the business size, annual receipts (average gross revenue) for the last three (3) fiscal years, and whether or not the firm has been approved as a small business by the SBA under the applicable NAICS code; and 4) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. Organizations responding to this market survey should keep in mind that only focused and pertinent information is requested. If significant subcontracting is anticipated for this effort, organization must show that they are technically capable by addressing the administrative and management structure of the subcontracting agreement. The agreement must show that small business prime contractors can maintain a full-time labor force, has technical capacity, management control, and meet the limitations on subcontracting imposed on small business set-asides. Interested firms responding to this survey are encouraged to structure capability statements in the order of the areas of consideration noted above. Please provide one (1) printed copy and an electronic copy of a tailored capability statement, which should not exceed ten pages in length, excluding resumes. In addition, the capability statement must provide sufficient details to determine the technical capability of your firm. The technical capability statements must be received by close of business on July 25, 2008. This market survey is being conducted through FedBizOpps in order to reach the widest possible audience and to gather current market information. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; therefore, any response to this market survey is voluntary; the Government assumes no financial responsibility for any costs incurred. Correspondence regarding this announcement, may be submitted to National Heart, Lung, and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Room 6128, Bethesda, Maryland 20892-7902, Attention: Donald L. Ervin, Contracting Specialist, or emailed to ervindl@mail.nih.gov